NEW YORK: The US FDA on Friday called for a federal investigation of the process that led to its own approval of a new drug for Alzheimer’s disease that has spurred criticism from lawmakers and medical community.
FDA’s acting commissioner, Janet Woodcock, acknowledged the scrutiny the agency has faced about the approval process for the drug, Aduhelm, which has a $56,000 annual price tag.
She pointed to interactions between representatives from the drug’s developer, Biogen, and the agency, saying some “may have occurred outside of the formal correspondence process”.